The Chennai based pharma major, Orchid Chemicals & Pharmaceuticals Ltd., announced that its sterile API (Active Pharmaceutical Ingredient) product Cefazolin, has formally received an approval from the US FDA. An important sterile cephalosporin antibiotic API, Cefazolin is used in the treatment of several infections. Orchid has established world-class sterile lyophilisation and non-sterile facilities for integrated manufacture of this product.

According to company sources, this approval received for a sterile product is indicative of the high quality standards, processes and regulatory compliance norms that Orchid has in place, especially for injectable cephalosporins.

"This is definitely a very key development for Orchid and another significant milestone in our regulatory roadmap. This approval would enable a strong entry for our sterile injectable product, Cefazolin into the US market. We hope to start exports of this product to the US soon. Over the last 12 months, we have had inspections and received approvals from several leading international regulatory agencies. We are hopeful of taking more of our products and facilities through these approval processes during the next calendar year", said K Raghavendra Rao, managing director, Orchid Chemicals & Pharmaceuticals, in a media release.